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Search theses and dissertations gathered from participating repositories worldwide. Every result links back to the library that holds it. No account is needed.
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Showing 1 to 20 of 21 for “"Critical Quality Attributes"”.
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Critical Quality Attributes of Topical Semi-solid Dosage Forms: Solvent Activity
Critical quality attribute has been defined as “a physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality”. Deviations from preset quality metrics may potentially result in …
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The impact of variation in freezing and thawing process parameters on the critical quality attributes of a monoclonal antibody
Therapeutic proteins or biopharmaceuticals have been playing an ever-increasing role in the treatment of human diseases over last 40 years. One of the main challenges with manufacture of these proteins is the stabilization of both the finished product and its processing intermediates during …
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An Investigation of Multivariate Process Control for Biomanufacturing
… individual loops by evaluating impact on control quality. A multivariate simulation environment was created to model the reactions of different control schemes on the critical quality attributes under investigation. This study reveals that model predictive control can be used on bioreactor control …
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DEVELOPMENT OF NOVEL DESIGN AND CONTROL APPROACHES FOR INTEGRATED CRYSTALLIZATION OPERATION AND SYSTEMS
… that the desired process requirement and product critical quality attributes (CQAs), including process yield, crystal purity, crystal size distribution (CSD), crystal shape and polymorphic form can be obtained. Studies about cooling or antisolvent only batch crystallization of pure APIs have been …
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Development of an Intelligent Heart-Cut Liquid Chromatography System for Chiral Analysis of Chemical Processes
… to monitor multiple essential and sometimes, critical quality attributes (CQAs) in parallel. A unique three-column, four-dimension liquid chromatography system employing a two-loop heart-cut strategy is reported. The system is capable of re-circulating effluents from each dimension through a …
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Industry 4.0 in Biomanufacturing: Predictive Real-Time Models Using Process Analytical Technology
… become an essential tool for improving product quality, reducing costs, and increasing efficiency. In this thesis, we collect capacitance and optical density data from two in-line sensors in production bioreactors to compute real-time readings of viable cell density (VCD) and viability, two …
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Smart Data Analytics for Manufacturing Processes
… for two monoclonal antibody products to predict critical quality attributes. Different approaches are introduced to consider both secondorder and third-order tensorial data combined as possible inputs to the predictive modeling. It is shown that the utilization of the proposed methods is capable …
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Predictive Disintegration Process Modelling of Immediate Release Tablets Using Terahertz Technology
In the drug product development process, linking Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs) to Critical Quality Attributes (CQAs) like disintegration performance is essential, particularly during scale-up. Predicting disintegration for immediate-release tablets …
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Near-Infrared (NIR) Spectroscopy-based Pharmaceutical Process Analytical Technology (PAT) Systems: Risk and Performance
… operations through timely measurements of critical quality attributes of raw/in-process materials, with the goal of ensuring quality of final drug products.</p> <p>Near-Infrared (NIR) spectroscopy is a commonly used analytical part of the PAT toolbox. It offers advantages such as …
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Hot-melt extrusion: A versatile pharmaceutical technology
… systems via hot-melt extrusion (HME) using Quality by Design (QbD) principles. Fenofibrate SLN were prepared by combining two processes: HME technology for melt-emulsification and high-pressure homogenization (HPH) for size reduction. Varying the process parameters enabled the production of …
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Performance-Based Quality Specifications: The Link between Product Development and Clinical Outcomes
… and their corresponding dosing guidelines are critical product development functions supported by clinical pharmacokinetic (PK) and pharmacodynamic (PD) data. Largely, the importance of variance and covariance in product and patient attributes is poorly understood. The existence of PK/PD …
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Machine learning for applications in chemical and biological engineering
… the first case study, the problem of predicting critical quality attributes for a monoclonal antibody using data from the manufacturing process is addressed. In this setting, the main challenge is that there is only a limited dataset available for modeling. To tackle this issue, Monte Carlo …
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Integration of quality-by-design into control systems design for continuous pharmaceutical manufacturing
… been much interest in design spaces: sets of critical process parameters (CPPs) which guarantee that critical quality attributes (CQAs) of a manufacturing process are within specifications. For continuous pharmaceutical processes, design spaces are usually calculated by assuming steady state …
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Quality by Design Approach to Advanced Particle Engineering, Process Optimisation and Upscaling of Electrohydrodynamic Atomisation Technology
… by carrying out a risk assessment (RA) of the critical quality attributes (CQAs) and critical process parameters (CPP) and using these to establish a quality target product profile (QTPP) yielding nanocrystals of desired particle properties with 395nm size. The nanonisation of crystal particles …
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DEVELOPMENT OF SUPERSATURATED MATRIX SYSTEMS FOR POORLY WATER-SOLUBLE COMPOUNDS BASED ON SPRAY-DRIED SOLID DISPERSIONS
… process parameters in order to control the critical quality attributes (CQAs) of final formulations. A 3×4 full factorial design was conducted to understand the effect of drug loading level and polymer type on the performance of SDD products for both glipizide and gliclazide. Drug loading …
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Data-driven Dynamic Control Scheme for Antibody Producing CHO Cell Cultures in Fed-batch
… to achieve high efficiency and enhanced quality control. High non-linearity and uncertainties associated with bioprocesses challenge the ability of traditional controllers to deliver satisfactory performance, thereby creating a need for advanced model based control strategies for …
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Automated Optimization and Control of Modular Chemical Systems
… production time, drug costs, waste, and product quality variations. Continuous pharmaceutical manufacturing in compact modular systems provides additional flexibility in where and when the drug is produced. The transition to continuous operation raises new control challenges to meeting …
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Measurement, optimisation and control of particle properties in pharmaceutical manufacturing processes
… in the manufacturing process or to influence Critical Quality Attributes (CQAs) linkedto product performance. This work aims to demonstrate experimental means to support a rational development approach for pharmaceutical particulate systems with a specific focus ondroplet drying platforms such …
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Model-based Design and Control of Biopharmaceutical Manufacturing Processes
… (PAT) is providing on-line measurements of critical quality attributes (CQAs) for constructing first-principles and data-based models of each unit operation and enable advanced control, (2) a transition from batch to continuous operation provides process control needs to handle the …
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Using an In Vitro-In Vivo Correlation for the ‘Bioequivalence by Design’ Development of an Immediate Release Carbamazepine Product
<p>The quality of a drug product may be characterized by the consistency with which its indicated clinical effect, and safety profile, is experienced by the patient. The concept that such quality should be built into a product is at the core of the United States Food and Drug Administration’s (FDA) …
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